Role of Lung Ultrasound in Weaning From Mechanical Ventil... | NCT03921112

Studies
Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients

NCT03921112

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 19, 2020Actual

Enrollment

130Actual

Phase

Not Applicable

Conditions

Intensive Care (ICU)

Interventions

lung ultrasound
routine tools

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2019Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Oct 1, 2019Actual

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

Apr 17, 2019

First Posted Date

Apr 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2020

Last Update Posted Date

May 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amin Mohammed Alansary Amin Ahmed Helwa, Assistant professor, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to demonstrate the role of lung ultrasound in weaning from mechanical ventilation in neurosurgical ICU patients compared to the ordinary tools as chest X-ray , ABG, rapid shallow breathing index, ventilator parameters.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lung ultrasound	Active Comparator		Device: lung ultrasound Other: routine tools
x-ray, ABG, RSBI, Vetilator parameters	Active Comparator		Other: routine tools

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lung ultrasound	Device	bedside lung ultrasound will be done for patients	lung ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
success of weaning	trans-thoracic lung ultrasound will be done to patients to start weaning	success of weaning for 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mechanically ventilated patients
ASAI ,ASAII, ASAIII

Exclusion Criteria:

Patients or gurdians refuse
Patients with pneumthorax
Patients with pleural effusion
Patients with surgical emphysema
Glasco coma score more than 8
Patients on high inotropic support
patients with diaphragmatic paralysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amin m Alansary	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University hospitals		Cairo		11591	Egypt